A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants

Recruitment & Eligibility

Inclusion Criteria

Male or female Chinese participants whose parents and maternal and paternal grandparents are of Chinese ethnicity
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and until Day 113
A male participant must agree not to donate sperm for the purpose of reproduction and must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and until Day 113
A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) at screening and a negative urine pregnancy test on Day -1 and while enrolled in this study
Nonsmoker or agree to smoke no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day throughout the study, if the inpatient unit allows. However, if smoking is not allowed in the inpatient unit, smokers will not be allowed to smoke while inpatient and cannot use nicotine replacement products during the inpatient period

Exclusion Criteria

History of any clinically significant medical illness or medical disorders the investigator considers should be exclude the participant, including (but not limited to) liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Had major illness or surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or until Day 113
Plans to undergo non-major elective surgery within 4 weeks prior to study intervention administration through the end of the study
Known or suspected allergies, hypersensitivity or intolerance to JNJ-64304500 or any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs or antibody fragments, or to any components of the formulation of JNJ-64304500 and its excipients used in this study

Study & Design

Arm && Interventions

Group	Intervention	Description
Cohort 2: JNJ-64304500	JNJ-64304500	Participants will receive single SC Dose 2 of JNJ-64304500 on Day 1.
Cohort 1: JNJ-64304500	JNJ-64304500	Participants will receive single subcutaneous (SC) Dose 1 of JNJ-64304500 on Day 1.

Primary Outcome Measures

Name	Time	Method
Serum Concentration of JNJ-64304500	Up to Day 113	Serum samples will be analyzed to determine concentrations of JNJ-64304500 using a validated, specific and sensitive immunoassay method.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	Up to Day 113	An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Number of Participants with Antibodies to JNJ-64304500	Up to Day 113	Number of participants with antibodies to JNJ-64304500 will be reported.

Recruitment & Eligibility